FDA 21 CFR Part 11

 

The US Food and Drug Administration (FDA) has established Part 11 of Title 21 of the Code of Federal Regulations (FDA 21 CFR Part 11), which contains safety requirements for life science companies. These requirements ensure that electronic records and signatures are legitimate and authentic, allowing them to replace their paper counterparts in many situations. Many companies also apply FDA 21 CFR Part 11 to improve the security and reliability of IT systems.

 

Demand for drugs has been increasing significantly, while regulatory agencies tighten the approval process for new drugs. Strong regulation poses many challenges to the industry, requiring companies to direct their efforts to ensure that stringent quality and compliance standards are met. In this way, they prevent products from presenting quality and safety problems, which can result in fines or legal penalties and weaken the company's image, directly impacting revenue and market share. https://www.eleapsoftware.com/21-cfr-part-11/

 

The solution to FDA 21 CFR Part 11

SoftExpert offers the most comprehensive and advanced software solution for compliance management that meets the requirements of the most diverse global regulatory standards. The SoftExpert Excellence Suite  helps companies in compliance with FDA 21 CFR Part 11 requirements, while increasing security and reducing the risks and operating costs.

 

The SoftExpert solution allows organizations to easily meet the requirements of FDA 21 CFR Part 11, through resources for managing documents, records, reviews, access control, audit trail, in addition to non-conformities, indicators, processes, among others , increasing organizational efficiency and avoiding rework and waste.

 

With online collaboration capabilities, the organization and its managers have greater visibility and can stay up-to-date on regulatory compliance initiatives. The solution integrates users, teams and departments through standardized processes, simplifying the entire process of preparing for FDA audits.

 

Main benefits of the solution

Ø  Reduces efforts to comply with FDA, ISO and other regulations.

Ø  Simplifies the preparation, review and approval of regulatory documents.

Ø  Prevents the existence and use of duplicate and obsolete documents.

Ø  It only guarantees access to current documents and avoids process deviations.

Ø  Ensures availability and traceability of information for FDA audits.

Ø  Promotes the company's commitment to quality and customer safety.

Ø  Provides customers with a better experience with products and services.

 

  Implications Of 21 CFR Part 11 For The Industry 

 

 

By introducing the 21 CFR Part 11 regulation, the FDA have basically enabled the Life Science community and other FDA regulated industries to streamline business procedures, automate constructing supply bonds, reduce turnaround time and costs, reducing risk of human errors all by establishing standard criteria for the use of electronic records and signatures.

 

 

 

However, to utilize these noteworthy benefits, FDA modulated companies must maintain requisite features in their organizations, establish Standard procedure, and perform regular Method Validation.

 

 

 

 

 

  What is FDA Regulation 21 CFR Part 11 ?

 

 

FDA Regulation Title 21 CFR Part 11( also known as 21 CFR 11 ), Electronic Records/ Electronic Signatures, is the part of the Code of Federal Regulations that establishes the United Nation Food and Drug Administration( FDA) regulations on electronic records and electronic signatures. Exclusively, 21 CFR 11 defines the requirements for submitting documentation in electronic form and the criteria used for approved electronic signatures.

 

 

 

  Who needs to comply with FDA Regulation 21 CFR Part 11 ?

 

 

All FD-Regulated industries, which includes pharmaceutical, production processes medical inventions, nutrient& refreshment manufacturers and cosmetics companies, must conform to 21 CFR 11. Computer organizations( including analytical instruments with onboard computers) which store or produce data to stir excellence verify decisions, or reporting data for the FDA must comply with 21 CFR 11. This includes any laboratory answers used to determine quality, refuge, forte, efficacy, or integrity. In manufacturing environments, this includes data used to make decisions related to product release and product quality.